Who Should Try PrEP?

Mascolini: For whom should US clinicians prescribe PrEP?

Grant: Broadly speaking, PrEP is for people potentially exposed to HIV infection. In the United States one key group consists of young men of color in urban centers that have an identified epidemic. PrEP candidates also include their partners, who may be women, and other people potentially at risk for acquiring HIV.

I think the most important point is that PrEP is for people who want it. Anyone who comes forward and says they're interested in finding new ways to protect themselves and their partners from HIV should receive prevention services, regardless of whether we can easily identify a risk factor. I say that because most of the language that we use about "risk groups" and "risk factors" is stigmatizing, off-putting, and insulting. It seems to me that if someone has come forward and says, look, I want PrEP, or I want to explore this, the answer should be yes. If anyone says, I want to find ways of keeping myself free of HIV, the answer should be yes.

Mascolini: Are you saying that if a man or a woman seeing a healthcare provider says they want PrEP, the provider shouldn't say, well, how many sex partners do you have, or do you use condoms consistently?

Grant: It's fine to explore these issues and to engage in such a conversation. But I think many clinicians are not prepared to have a nonjudgmental discussion about numbers of partners and sexual practices and similar issues. Clinicians need to think seriously about whether they're prepared to have a nonjudgmental conversation with a patient. If they are prepared, then by all means that kind of conversation can be useful.

This field is evolving rapidly. I think we need to help healthcare providers learn more about sexual health and ways of promoting sexual health in nonjudgmental ways. That process takes some time. In the meantime, when someone asks for prevention services, the answer should be yes.

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Mascolini: Do you think heterosexual men and women with some risk of HIV infection are going to use PrEP in the United States?

Grant: Yes, I think they will sometimes. Certainly for heterosexual couples with one negative and one positive partner who desire pregnancy, PrEP is a very attractive option. Another alternative is suppressive therapy for the infected partner, which is also highly effective in preventing transmission.2 But sometimes the negative partner may not have complete faith in their partner's ability to take antiretroviral therapy in a fully suppressive way. In those cases PrEP becomes an additional safeguard to allow intimate sex and pregnancy while lowering the risk of HIV transmission.

Identifying heterosexuals who need HIV prevention services has been a challenge in the United States. Again, I think that if we can find less stigmatizing ways of talking about HIV and sex, people will be more willing to come forward and ask for prevention services if they need them.

Mascolini: So far PrEP clinical trials that enrolled heterosexuals took place in Africa.3-5 Can US and European clinicians be sure PrEP will work in heterosexual men and women outside Africa?

Grant: Yes. The Partners PrEP study3 and the TDF2 study4 both demonstrated that oral TDF/FTC is highly effective in heterosexual populations. Both of those studies were done in Africa, but the biology of heterosexual transmission is very similar around the world. I think that in heterosexual populations, as with gay men, adherence to PrEP is very important. It will not work if it is not used, and we've seen that in our research.1,3-5 PrEP will fail if it's not used sufficiently to attain detectable drug levels in the body.

Mascolini: iPrEx had a small contingent of transgender participants, and your iPrEx abstract for the 2011 IAS meeting showed no protection of transgender participants.6 Should clinicians consider PrEP for male-to-female transgender people?

Grant: I think they can consider it. In iPrEx we found that transgender women had detectable drug in their blood less frequently than other subgroups. We believe the trans subgroup in our study had more difficulty with adherence and that likely explains the lack of protective effect in that subgroup.

Importantly, there were insufficient numbers of trans women in iPrEx to know whether PrEP can work for them, so we're not sure yet whether PrEP efficacy is similar in trans women compared with gay men. But I think PrEP with tenofovir/emtricitabine [TDF/FTC, Truvada] is an option for trans women. Certainly, they should be aware that there's less information available about how well it works for them and that adherence was particularly challenging for trans women in iPrEx, we think for social reasons.

Everyone should realize that PrEP is highly effective if taken, but it is harder to take than people imagine. It does require taking a pill a day. People have to be organized to build that into their lives. They have to have an ongoing relationship with their healthcare provider.

Mascolini: Do you have a sense of whether many clinicians are starting to prescribe PrEP in the United States?

Grant: I think it's just beginning. As I go around the United States giving talks, typically there's one clinician in every room in virtually every city I've visited who is currently prescribing PrEP. But it really hasn't taken off as a common practice. I think providers are still trying to learn how best to use it and how best to inform people's decisions about whether PrEP is right for them.

Mascolini: When you give these talks around the country, what are the primary PrEP concerns your audiences ask about?

Grant: They're concerned about who should be offered PrEP, and I usually emphasize that people who want it should be offered PrEP. People's initiative is really the key thing to nurture at this point. We're trying to build a prevention initiative across the country so that we can see an AIDS-free generation.

Clinicians are interested in long-term as well as shortterm side effects, as well as tolerance issues. They want to know when to start and when to stop PrEP. Does it have to be taken daily? Are there alternative regimens that are just as good? And then the practical questions: Who's going to pay for it and how can it be made available within our existing healthcare system?

Mascolini: Are third-party payers paying for PrEP?

Grant: I believe they are all paying for it. The payers in the United States have decided not to require HIV testing results before paying for antiretroviral medications, and they do realize this means they are paying for PrEP. Preventing HIV infection potentially saves 40 years or more of antiretroviral therapy costs. People who are taking antiretroviral therapy for infection still have an excess risk of cancer and heart disease, which obviously cause a lot of suffering, but they're also very expensive conditions to treat.

Insurance companies are very happy to see money spent on HIV prevention -- it saves them money in the end. So generally they've been supportive of PrEP. The payers are not advertising that they have positive policies regarding PrEP, but they certainly have decided to pay for it the way they have been so far.

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